BEUDAMED
    FDA Adverse Event Other Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3556949 · Received December 23, 2013

    Report

    Report Number
    3008011247-2013-00064
    Event Type
    Other
    Date Received
    December 23, 2013
    Date of Event
    November 27, 2013
    Report Date
    November 27, 2013
    Manufacturer
    TRIVASCULAR, INC
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBABLE CAUSE OF THE TYPE IA ENDOLEAK IS MOST LIKELY TENSION ON THE GRAFT DURING OR AFTER POLYMER FILL, WHICH IN THE CURVED AORTA PULLED THE SEAL SING LATERALLY AWAY FROM THE AORTIC WALL, RESULTING IN A REGION OF COMPROMISED VESSEL APPOSITION AND LACK OF SEAL.

    Description of Event or Problem · 1

    THE PT UNDERWENT ENDOVASCULAR REPAIR OF AAA WITH THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2013. FOLLOWING POLYMER FILL OF THE AORTIC BODY, THE GRAFT DID NOT APPEAR TO HAVE APPOSITION WITH THE VESSEL WALL ON THE OUTER CURVE AND WAS OBSERVED TO BE TWISTED FROM THE PRIMARY SEALING RING TO THE DISTAL AORTIC BODY LEG. AFTER THE ILIAC LIMBS WERE IMPLANTED, FINAL ANGIOGRAPHY INDICATED A TYPE IA ENDOLEAK REMAINED ON THE OUTER CURVE. THE SEAL ZONE WAS DILATED WITH A BALLOON BUT THE ENDOLEAK WAS NOT RESOLVED. THE STENT WAS POSITIONED AT THE SEALING RINGS, COVERING THE RENAL ARTERIES. THE AORTIC BODY WAS BALLOONED AND THE PHYSICIAN OBSERVED THAT THE AORTIC BODY STRAIGHTENED SOMEWHAT, HOWEVER, A SMALL TYPE IA ENDOLEAK PERSISTED. A STENOSIS IN THE IPSILATERAL LEG OF THE AORTIC BODY GRAFT WAS OBSERVED AND A STENT WAS PLACED FOLLOWED BY BALLOONING. THE PHYSICIAN ELECTED TO MONITOR THE TYPE IA ENDOLEAK AT THE 1 MONTH F/U. BASED ON A REVIEW OF INTRAOPERATIVE IMAGING, THE ROOT CAUSE OF THE AORTIC BODY GRAFT TWIST IS INCONCLUSIVE. THE RADIOPAQUE MARKERS OF THE CATHETER INDICATE THAT THE CATHETER WAS ROTATED PRIOR TO PROXIMAL STENT DEPLOYMENT, BUT IT COULD NOT BE DETERMINED IF THIS CONTRIBUTED TO THE GRAFT TWIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672543 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM MIH TRIVASCULAR, INC TV-AB2680-D FS080513-40

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other